DeviceClearance

Product code LIB— Microbiology

AUTO MASH

Classification name
Device, General Purpose, Microbiology, Diagnostic
Device class
Class 1
Regulation
21 CFR 866.2660
Advisory panel
Microbiology
Total cleared
43
First cleared
Most recent

Market context for product code LIB

FDA has cleared 43 devices under product code LIB between 1981 and 2003, filed by 22 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code LIB

Recent clearances under product code LIB

Data sourced from openFDA. This site is unofficial and independent of the FDA.